MCRA LLC, a medical device advisory firm and contract research organization with specialization in regulatory affairs, clinical research, reimbursement, compliance, and quality assurance, has implemented a call center to keep medical device manufacturers informed of government and site decisions that impact regulatory submissions, clinical study operations, or quality systems as a result of the COVID-19 pandemic. MCRA’s toll free coronavirus hotline can be contacted by phone at 877-796-8411 or by email at info@mcra.com.
 
MCRA is committed to the health and safety of individuals and to the industry as a whole and is offering guidance and services to help companies efficiently navigate the regulatory process to bring technologies to market in the United States to aid in the diagnosis, monitoring, and prevention of COVID-19. Worldwide, the virus has infected 428,220 people and killed 19,101 others. More than 109,000 people have recovered from COVID-19; the United States has reported 55,330 cases and 804 deaths as of March 25.

MCRA is in discussions with multiple companies seeking to pursue the U.S. Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) regulatory pathway for devices or diagnostics for COVID-19. This unique regulatory mechanism was developed to permit access to unapproved medical products or unapproved uses of approved medical products during times of emergency when there are no adequate or approved alternatives available.  
 
Products MCRA is supporting include, but are not limited to, personal protective equipment, test kits for clinic and at home uses, ventilators, cardiopulmonary monitoring systems, and respiratory treatment devices. 
 
MCRA’s COVID-19 taskforce is keeping up to date with new information and guidance documents released by FDA. Glenn Stiegman, MCRA’s senior vice president of Clinical & Regulatory Affairs, said, “MCRA remains in constant contact with FDA and other constituents to stay on top of and implement necessary actions to help our clients, partners, and colleagues during the coronavirus crisis. We welcome the opportunity to provide support as it relates to COVID-19’s impact on decisions regarding changes to study conduct or regulatory strategies and whether documentation should be submitted to FDA.”